Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke
- Registration Number
- NCT01623622
- Lead Sponsor
- Asahi Kasei Pharma Corporation
- Brief Summary
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Inclusion Criteria
- Patients with severe upper limb hemiplegia after stroke
- Within 28 days after stroke at enrollment
Exclusion Criteria
- Patients with sensory loss between shoulder and hand on paralyzed side
- Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - HC-58 low dose HC-58 Low dose HC-58 high dose HC-58 High dose
- Primary Outcome Measures
Name Time Method Onset of shoulder hand syndrome 12 weeks The incidence rate of shoulder hand syndrome
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency 12 weeks MBI efficiency means MBI gain divided by period of administration
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency 12 weeks FMA efficiency means FMA gain divided by period of administration
- Secondary Outcome Measures
Name Time Method Swelling asymmetry between hands 12 weeks Discolouration of the skin of the hand 12 weeks Bone metabolic marker 12 weeks Pain score by numeric rating scale 12 weeks Difference in skin temperature between hands 12 weeks Decreased range of motion 12 weeks Radiographic finding of bone 12 weeks